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Method for detecting bacterial endotoxin in Danshen injection

A technology of bacterial endotoxin and Danshen injection, which is applied in the field of medicine, can solve the problems of incapable quality control, cumbersome and time-consuming operation, etc., and achieve the effects of reducing inspection cost, fast method, and convenient production process monitoring and inspection.

Pending Publication Date: 2019-02-26
SICHUAN SUNNYHOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, in the prior art, the detection method for bacterial endotoxin in Danshen injection is cumbersome and time-consuming, and cannot be used for quality control in the production process.

Method used

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  • Method for detecting bacterial endotoxin in Danshen injection
  • Method for detecting bacterial endotoxin in Danshen injection
  • Method for detecting bacterial endotoxin in Danshen injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0019] 1. Experimental materials and instruments

[0020] 1.1 Limulus reagent

[0021] Marked sensitivity (λ) 0.125EU / mL, specification 0.1mL / bottle, batch number 1712182; labeled sensitivity (λ) 0.06EU / mL, specification 0.1mL / bottle, batch number 1607202, valid for two years, Zhanjiang Andus Biological Co., Ltd. Company production. Labeled sensitivity (λ) 0.25EU / mL, specification 0.1mL / bottle, batch number 16060312; labeled sensitivity (λ) 0.125EU / mL, specification 0.1mL / box, batch number 17080912; labeled sensitivity (λ) 0.06EU / mL, specification 0.1 mL / tube, batch number 17061112 is valid for two years, produced by Fuzhou Xinbei Biochemical Industry Co., Ltd.

[0022] 1.2 Bacterial endotoxin inspection water

[0023] Specification 100mL / bottle, batch number 170322, containing bacterial endotoxin <0.003EU / mL, produced by Zhanjiang Andus Biological Co., Ltd.

[0024] 1.3 Bacterial endotoxin working standard (lyophilized)

[0025] Potency 80EU / bottle, batch number 150601-2...

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Abstract

The invention discloses a method for detecting endotoxin in a Danshen injection, and belongs to the field of medicines, and the method comprises the following steps: (1) determination of endotoxin limit value L; (2) sensitivity check of tachypleus amebocyte lysate; (3) interference test pre-testing for determining that a to-be-tested sample is diluted by a factor of 20; (4) interference tests of the to-be-tested sample for determining that non-interfere dilution factor is 80; and (5) detecting of the bacterial endotoxin in the to-be-tested sample. The method is rapid and sensitive. After determining the endotoxin limit value L and the dilution factor, the to-be-tested sample can be directly tested, no test is required to determine the dilution factor, while the detection accuracy is ensured, the inspection cost is reduced, the inspection efficiency is improved, and production process monitoring and inspection work are convenient.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a detection method for bacterial endotoxin of salvia miltiorrhiza injection. Background technique [0002] Bacterial endotoxin is a unique structure on the cell wall of G-bacteria, and its main component is lipopolysaccharide, which has strong pyrogenic activity. When endotoxin enters the blood through injection and other means, it will lead to different degrees of endotoxemia. Therefore, bacterial endotoxin control should be carried out for injections to ensure product quality and drug safety. [0003] The common methods for detection of bacterial endotoxin are rabbit pyrogen method and limulus reagent method, and the limulus reagent method is more widely used at present. Before using this method for bacterial endotoxin detection, an interference experiment must be carried out to eliminate the interference of the test product on the LAL experiment and ensure the accuracy o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/579G01N1/38
CPCG01N1/38G01N33/579G01N2333/195
Inventor 杨强黄筱萍李涛廖远征王瑾姚欣蒲虹橙唐茜
Owner SICHUAN SUNNYHOPE PHARM CO LTD
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